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August 14th, 2014
10:12 AM ET

New at-home test may detect colon cancer

The U.S. Food and Drug Administration has approved an at-home colon cancer test. Called Cologuard , it is the first stool-based screening test that detects certain DNA mutations and red blood cells that could be indications of colorectal cancer, according to the FDA. The test, which is ordered through a doctor's office, can be done at home.

"Unlike many other screening options, Cologuard does not require medication or dietary restrictions, or bowel preparation prior to taking the test," the manufacturer says.

The FDA says Cologuard could be used to help determine who is at risk of developing colorectal cancer at its earliest stages when the cancer is still asymptomatic. The agency approved the test this week.

Most cases of colorectal cancer begin as small polyps attached to the walls of the large intestine or rectum. Colorectal cancer primarily affects men and women over the age of 50. And in most situations it is preventable. If caught in time, the FDA says at least 60% of colorectal cancer deaths could be avoided.

The new stool-based test detects certain abnormalities associated with colorectal cancer cells. Patients who test positive with Cologuard would be advised to undergo further tests, including a colonoscopy.

"This approval offers patients and physicians another option to screen for colorectal cancer," said Alberto Gutierrez, director of the Office of In Vitro Diagnostics and Radiological Health at the FDA's Center for Devices and Radiological Health. "Clinical data showed that the (new) test detected more cancers than a commonly used fecal occult test."

Fecal occult blood tests, or fecal immunochemical tests, are previously approved screening tests that can be done once a year at home. The American Cancer Society recommends people with an average risk for colorectal cancer also have a flexible sigmoidoscopy every five years or a colonoscopy every 10 years.

Although it adds another method for detecting some cases of colorectal cancer, the new at-home test has both pros and cons, says Dr. Won Kyoo Cho, chief of gastroenterology/hepatology at MedStar Washington Hospital Center in Washington.

"When it comes to spotting more abnormalities the test is very good. The Cologuard picks up about 92.3% of abnormalitites, compared to 74% with the FIT (fecal immunochemical test)."

But Cho warns, "The downside is the new test was not as good at finding 'true negatives.' ” Cologuard correctly identified a negative result in 87% of patients, the FDA says; the fecal immunochemical test correctly identifies negative results about 95% of the time.

"That means you may be picking up abnormalities, but it doesn't necessarily mean those abnormalities are cancerous, so the false positives are higher," Cho says. "Many people who test positive on the test may be worried for no reason."

The approval of Cologuard does not mean current colorectal cancer screening guidelines have changed. The FDA notes that stool DNA testing is not currently recommended to screen for colorectal cancer by the U.S. Preventive Services Task Force. The task force still believes patients between the ages of 50 to 75 should be screened using fecal occult blood testing, a sigmoidoscopy or a colonoscopy.

A colonoscopy is the "gold standard" in colorectal cancer detection.

"(Cologuard) doesn't really detect polyps that could be the beginning of colon cancer," Cho said. "When you go in with a colonoscopy, you can snip those polyps out immediately. Done. But if you miss those polyps and they grow in the colon, you could be facing serious surgery, or even the possible spread of the cancer."

At this point, the main issue with Cologuard is cost. According to Cologuard's manufacturer, one test costs as much $600. But the FDA noted on the same day of the test's approval, the Centers for Medicare and Medicaid Services issued a proposed national coverage, meaning Medicare will pay for the test once every three years for beneficiaries who meet a certain criteria.

"This is the first time in history that FDA has approved a technology and CMS has proposed national coverage on the same day," said Patrick Conway, chief medical officer and deputy administrator for innovation and quality for the Centers for Medicare and Medicaid Services. "This parallel review ... will provide timely access for Medicare beneficiaries to an innovative screening test to help in the early detection of colorectal cancer."

Cho adds, "The fecal tests we use now cost as little as $20, which means you can afford to have one done every year. But hundreds of dollars - no wonder Medicare will only pay for it every three years."


soundoff (2,121 Responses)
  1. Diane

    Still nothing where you can truly test yourself at home ie without sending it to a lab and having to go through a doctor? How many people avoid testing altogether because of the invasiveness of having third parties involved in the process?

    August 18, 2014 at 16:09 | Report abuse | Reply
    • Patty

      A colonoscopy is less invasive, less embarassing and less painful than the yearly ob/gyn exam.

      September 26, 2014 at 12:07 | Report abuse |
    • Eben

      The person's personal information, is never revealed, except between the patient and his/her doctor, for the purpose of disclosing the results of the test.

      November 8, 2014 at 12:01 | Report abuse |
    • Mary

      I agree.

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  2. firehairedwoman

    As a nurse we did simple screening test for rectal bleeding/symptoms of cancer. We put a stool sample on one side of a card, turned it over and put a solution on the back. If the paper turned blue, then it was suggested that you get further treatment. Granted it isn't fool proof, but I believe that if a woman can do a home pregnancy test, then your average Joe could perform this test. At least it might spur someone who might otherwise not, to seek out some help.

    August 19, 2014 at 03:21 | Report abuse | Reply
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    I would highly appreciate it if you could send me more information about this colon test.Can I order one.

    November 10, 2014 at 20:25 | Report abuse | Reply
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    This article is interesting in for so many reasons. I think we are entering a new age of medicine. With a very significant push towards prevention as opposed to treatment. The new age of technology will allow us to reach more people, quicker an dwith less hassle. I am aware of at least a few apps that are in developwmwnt for the recognition of early stage cancers. One in particular already being developed in Israel.

    Additionally, the age of telemedicine companieshas arrived and it will be easier and also much less costly to continue following patients at home.

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  16. Taylor borg

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    HOW TO GET YOUR EX BACK═══►
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    After 8 yrs of being married, my husband left me with two kids, I felt like ending it all, i almost committed suicide because he left us with nothing, i was emotionally down all this while. Thanks to a man called Dr.Unity, a real and powerful spell caster which i met online. On one faithful day, as I was browsing through the internet, I came across several testimonies about this particular man. Some people testified that he brought their Ex lover back, some testified that he restores womb,cure cancer,and other sickness, some testified that he prayed to stop divorce and get a good paid job so on. He is amazing, i also come across one particular testimony, it was about a woman called Kate , she testified about how he brought back her Ex lover in less than 2 days, and at the end of her testimony she dropped his email. (Unityspelltemple@gmail.com) After reading all these, I decided to give it a try. I contacted him via email and explained my problem to him and he told me what is needed to be done and i did it. In just 28hours, my husband came back to me. We resolved our issues, and we are even happier than ever. Dr.Unity you are a gifted man and thank you for everything you had done in my life. If you have a problem and you are looking for a real and genuine spell caster, contact him anytime, he is the answer to your problems. you can Email him at: Unityspelltemple@gmail.com ,you can also call or Add him on Whats-app: +2348071622464·

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  26. unityspelltemple

    My husband left me to be with another woman. and wanted him back.I was so frustrated and i could not know what next to do again, i love my husband so much but he was cheating on me with another woman and this makes him break up with me so that he can be able to get marry to the other lady and this lady i think use witchcraft on my husband to make him hate me and my kids and this was so critical and uncalled-for,I cry all day and night for God to send me a helper to get back my man until i went to London to see a friend and who was having the same problem with me but she latter got her Husband back and i asked her how she was able to get her husband back and she told me that their was a powerful spell caster called Dr.Unity that he help with love spell in getting back lost lover back, and i decided to contact the same Dr.Unity and he told me what is needed to be done for me to have my man back and i did it although i doubted it but i did it and the Dr told me that i will get the result after 28hours, and he told me that my husband was going to call me by 9pm in my time and i still doubted his word, to my surprise my husband really called me and told me that he miss me so much, Oh My God! i was so happy, and today i am happy with my man again and we are joyfully living together as one good family and i thank the powerful spell caster Dr.Unity of Unityspelltemple@gmail.com, he is so powerful and i decided to share my story on the internet that good spell casters still exist and Dr.Unity is one of the good spell caster who i will always pray to live long to help his children in the time of trouble, if you are there and your lover is turning you down, or your husband moved to another woman, do not cry anymore, contact this powerful spell caster Dr.Unity on his email: Unityspelltemple@gmail.com ,you can also call or Add him on Whats-app: +2348071622464 ,He is the best spell caster online.

    September 18, 2016 at 05:39 | Report abuse | Reply
  27. superlovespell

    Getting my Ex back . I've known Johnson for years, When we finally got together things were kind of weird so we broke up which was in February of 2013 In June of 2014 he and I recently got back together and we were together until march of 2015 which he told me he was not interested in relationship again During that time I changed completely, I wasn't eating,I was sleeping a lot, I wasn't talking to anybody, I cried a lot,I'm so depressed and stressed out that I'm scared I'm going to end up in the hospital because of all the stress and depression until one day i search online on getting love tips because I Love & care about him deeply and I just want us to be together as a couple again and I want us to last forever Google recommend me Makospelltemple@yahoo.com that he will solve my relationship problem then Dr Mako told me he will come back to me between 48hrs after he cast spell on him never believe it until my fiance called me on the phone and told me he want us to come back and live happy together forever , Am so happy now that DR MAKO, help me bring Johnson back to me. Thanks so much( Dr Mako) his email: Makospelltemple@yahoo.com or call him :+2347054263874.

    September 27, 2016 at 06:48 | Report abuse | Reply
  28. Dr.Unity

    My husband left me to be with another woman. and wanted him back. i was jealous and it made us argue all the time until he vanished away, I was desperate to get him back, I wasted so much time and money on getting my lover back after I have tried almost all possibilities to have him back and nothing worked. I became lonely for 2 years. To make it short, I found a spell caster Dr Unity by accident. I don’t know how I found him and i cant remember. But, when I first saw the good testimonies about his wonderful work and after reading the Testimonials, I decided I had to try and give it one last shot. After the spells, a miracle happened, my husband came home. it was awesome, anyone who needs help, should email, Unityspelltemple@gmail.com or you can also visit his website:http://unityspelltemple.yolasite.com ,He is the best. whoever need a spell caster that will work for you and bring back your lover should contact Dr.Unity.

    October 5, 2016 at 13:26 | Report abuse | Reply
  29. belinskey kapoor

    good day to anyone listening to my testimony, i really thank God for using dr ekuku in my life because i never believe i was going to be this happy again, my name is belinskey kapoor am from hessen germany, well my happiness is a good story to start a life because i never use to believe in spell, but today spell has brought into my life happiness because am very mush happy with my ex boyfriend again, i dated him three years we were so happy that we were always having it in mind that we were going to get married someday, but just last year my boyfriend said i was so ugly that he never love me anymore, well i was in a big pain , so i was just scrolling online just last week here and i saw much of testimonies of which this great man has done, some said they got healed from HIV, some said he make them conceive, some said he brought their home together again, some restoration of womb, and after i saw all this i said let me give this man a try, well i contacted him, so he said i have no problem, that my lover was going to come back withing 28 hours, so i waited, and after 28 hours my boyfriend called me on the phone,asking me to forgive him, well i did because i loved him, and now we are together again, so all thanks to dr ekuku, so if you have any problem or sickness at all contact him on his email now on his email :ekukuperfecthome@yahoo.com or visit him on his website :ekukuperfecthome.wixsite.com/dr-ekuku so run to him with your problems today and return with happiness, once again thank you great ekuku,

    November 30, 2016 at 06:05 | Report abuse | Reply
  30. Keith R

    This is an older post, but I would like to know if there are any updates to this story...
    Atlanta Car Accident Attorney 

    January 5, 2017 at 14:33 | Report abuse | Reply
  31. Lord Ogbomola

    I am Lord Ogbomola the high chief of Ogbomola palace, am a great herbalist and powerful spell caster with the great powers to get ex back, make people love you, win cases, get attracted to someone, get financial help and so many others.
    I am well known for the great powers I have and the fast results of my experienced works.
    Are you looking for a good spell to get back your ex lover, husband, wife, boyfriend or girlfriend?
    Do you want to win court cases?
    Do you want a spell to make yourself very attractive to men or women?
    Do you need financial assistants?
    Do you need powers to control anyone?
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    Do you want powers to get rich or famous?
    Do you need a cure to any disease such as HIV/Aids, Diabetes, Parkinson, ALS etc….
    Do you need Penis, Hips, Breast or Butt Enlargement?
    Do you need solution to Weak erection/premature ejaculation in men?
    Do you need connections to become a member of any occult group or society to get more richer?
    Do you want powers to make your business or any organization grow faster and higher? ETC……
    Then consider the Ogbomola Palace as the best place to be for the results and solutions you seek.
    For consultations on any marital or other problems, reach me immediately on my social email: OGBOMOLAPALACE@YAHOO.COM …

    March 4, 2017 at 15:12 | Report abuse | Reply
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  36. Odalice Feliz

    There is now a clear body of evidence that bowel cancer is more common among those who eat the most red and processed meat. Processed meat consumption has also been strongly linked to a higher risk of stomach cancer.
    The World Health Organization has classified processed meats – including ham, salami, bacon and frankfurts – as a Group 1 carcinogen which means that there is strong evidence that processed meats cause cancer. Red meat, such as beef, lamb and pork has been classified as a ‘probable’ cause of cancer. These classifications do not indicate the risk of getting cancer, rather how certain we are that these things are likely to cause cancer.
    Cancer Council estimates that in 2010, one in six (or 2600) new bowel cancer cases in Australia were associated with consuming too much red meat and processed meat.
    Lean red meat can be an important source of iron, zinc, vitamin B12 and protein. In terms of cancer risk there is no reason to cut meat completely from your diet, but there are steps you can take to reduce your risk.
    There is not enough evidence to draw any conclusions on eating poultry and the risk of cancer. However, eating fish may help to reduce the risk of bowel, breast and prostate cancer.
    Meat may affect cancer risk because of chemicals formed during digestion that have been found to damage the cells that line the bowel. Other likely factors include the fat content, and the way it is processed or cooked; or because big meat eaters miss out on other protective foods such as fruit and vegetables or wholegrain cereals.
    How much meat should I eat?
    To reduce your risk of cancer, Cancer Council recommends eating no more than 700 grams (raw weight) of red meat per week. For good health we need less than this. Aim for a small 65g serve of cooked meat each day or 2 serves (130g) 3-4 times a week. Avoid consuming more than 455g of cooked lean red meat each week.
    Cancer Council recommends people limit or avoid eating processed meats, which are high in fat, salt and nitrates. Because of the high fat and salt content of processed meats, the Australian Guide to Healthy Eating considers processed meats to be ‘discretionary choices’ that should only be eaten occasionally. (Examples of other discretionary choices that should only be eaten occasionally include fast food, cakes, confectionary and chips).
    Try to choose lean cuts of meat or chicken, have more fish and make sure you eat plenty of plant-based foods such as fruit, vegetables and wholegrain cereals.

    Read more at https://www.cancercouncil.com.au/21639/cancer-information/cancer-risk-and-prevention/healthy-weight-diet-and-exercise/meat-and-cancer/#MHgk3EB7I0SfaRoa.99

    September 17, 2017 at 12:10 | Report abuse | Reply
  37. Corey Edward

    How i get my ex girlfriend back:I need help in my relationship check on Dr Trust website and contact him now

    I"m Corey Edward from US Florida..This is my testimony on how my ex girlfriend come back home..i want to say a very big thanks and appreciation to Dr. Trust for bringing back my lover who left me. One day as i was browsing searching on the internet for recommend spell caster who will help me to bring my Ex Girlfriend back,Finally i met a writing how so many testimony talking about Dr. Trust who restore relationship back,so i email him and he cast the love spell,luckily within 24 hours my Girlfriend really called me and started apologizing for all she had caused me.and begging me to accept her back and we are living happily and our relationship is now very strong, I am the happiest man on earth today because Dr. Trust has done a wonderful deeds,my Gf now love and respect me. Email him for your relationship help. Or check on him on his website for others testimonies of his client.
    Ultimatespellcast@yahoo. com or Ultimatespellcast@gmail. com

    October 2, 2017 at 06:14 | Report abuse | Reply
  38. Alvin Lee

    Hey guys..

    Seeking for help on how to get your ex lover back or save your marriage? Unityspelltemple@gmail.com is certainly the best, and his result is 100% guarantee..

    October 21, 2017 at 01:16 | Report abuse | Reply
  39. Alexandria

    Seeking for help on how to get your ex lover back fast or save your marriage? Unityspelltemple@gmail.com is certainly the best, and his result is 100% guarantee..

    October 24, 2017 at 21:21 | Report abuse | Reply
  40. Alexandria

    Seeking for help on how to get your ex lover back fast or save your marriage? Unityspelltemple@gmail.com is certainly the best, and his result is 100% guarantee.

    November 5, 2017 at 03:57 | Report abuse | Reply
  41. Wendy Murray

    Effective powerful love spell to get your ex lover back now! Unityspelltemple@gmail.com is certainly the best spell caster online, and his result is 100% guarantee..

    November 13, 2017 at 10:13 | Report abuse | Reply
  42. Patricia Shiels

    Hello everyone my health is restore Dr. Ehiagwina cured me from HSV2 with Natural herbs remedy here’s his email; ehiagwinaherbalhome@gmail.com

    December 12, 2017 at 11:53 | Report abuse | Reply
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  43. Happy

    Urgently On Love Spell To Get Your Ex Boyfriend Back Contact Happylovespell2@gmail.com He Is The Best Of All On Love Spell That Work Fast

    January 12, 2018 at 21:15 | Report abuse | Reply
  44. lucy

    Greetings to everyone reading this message i'm Lucy by name am from Manchester and am using this opportunity to thank Prof Maduike Ezeibe,for the help he render to me i was diagnose of HIV virus which nearly took my life Prof Maduike Ezeibe, cured me from it with his herbal product he prepared for me i took the medicine for a period of two weeks even before the medicine finish i already received my healing, my doctor told me that HIV virus can not be cured he is so wrong am cured with prove of test am so grateful Professor Maduike Ezeibe indeed your words are your bond, this message is for those out there who is suffering from Hiv sickness or the other here is Prof Maduike Ezeibe, Email Address ; profmaduikeezeibe17@gmail.com you can reach him to get cured from that HIV. WhatsApp number +2349061392631

    February 1, 2018 at 21:49 | Report abuse | Reply
  45. Lin C

    Thanks Dr. Todd! My lover is back. I ordered the ULTIMATE LOVE SPELL and it took only 5 days to work... I feel so happy. I hope to get married soon! Todd's email: manifestspellcast@gmail.com

    March 20, 2018 at 08:08 | Report abuse | Reply
  46. credito.locali

    I no longer believed in lending money because all the banks rejected my file; In fact, I was stuck in my bank. But one day a friend advised me a particular lender, she gave me the email. I tried it with him by sending him an email and it worked. He had the right person, an honest individual lender who had been looking for years. I got my loan that allows me to live well now and I regularly pay my monthly payments. You can contact him if you need a loan for several personal reasons. Two of my colleagues also received loans without any difficulty.

    Here is your email: credito.locali.veloce@gmail.com

    April 20, 2018 at 00:56 | Report abuse | Reply
  47. unityspelltemple126848969

    Effective love spell to get lost lover back/stop divorce/save broken marriage"contact: Unityspelltemple@gmail.com is certainly the best spell caster online and his result is 100% guarantee! I'm so excited my husband is back after he have left me for another woman by spell caster called Dr.Unity, you can contact him if you have problem with your lover's his email: Unityspelltemple@gmail.com .

    April 22, 2018 at 03:41 | Report abuse | Reply
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  49. Joe

    Beware of online spell or to fix your broken marriage or relationship problem or after a divorce or Breakup,I was recently scam by two of them, until one faithful day i meet a man called Dr Oseiboh who help me to get back to the mother of my 2 kids after we have been separated for 3 years,I only pay for the items required for the spell and he cast the spell for me within 48hours my ex wife called me and beg me to forgive her for everything and we are back together.if you need a real and quick love spell or you are passing through pregnancy problem Dr Oseiboh is the answer, Please if any body needs. LOVE SPELL,LOTTERY,PREGNANCY SPELL, DIVORCE SPELL,STOP COURT CASE AND WIN ANY COURT PROBLEM,DEATH SPELL,BUSINESS SPELL AND MANY MORE YOU MAKE NEED. Email him now for your own help. via email droseiboh12@gmail. com https://droseiboh12.wixsite. com/spell add him on whatsapp line or call +2347017565415.

    July 31, 2018 at 22:28 | Report abuse | Reply
  50. Lin C

    Thanks Dr. Todd! My lover is back. I ordered the ULTIMATE LOVE SPELL and it took only 5 days to work... I feel so happy. I hope to get married soon! Todd's contact manifest spellcast@gmail. com

    November 23, 2018 at 07:03 | Report abuse | Reply
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Get a behind-the-scenes look at the latest stories from CNN Chief Medical Correspondent, Dr. Sanjay Gupta, Senior Medical Correspondent Elizabeth Cohen and the CNN Medical Unit producers. They'll share news and views on health and medical trends - info that will help you take better care of yourself and the people you love.